- Lead and mentor a team of engineers and technical staff, fostering a culture of innovation, collaboration, and excellence.
- Oversee the design and development of spine medical devices from concept through commercialization, ensuring adherence to project timelines, budget constraints, and regulatory requirements.
- Provide technical guidance and expertise in the areas of mechanical design, materials selection, manufacturing processes, and product testing.
- Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to address technical challenges, resolve issues, and optimize product performance.
- Drive continuous improvement initiatives to enhance product quality, reliability, and cost-effectiveness.
- Develop and maintain design control documentation, including design input requirements, risk assessments, verification and validation protocols, and technical reports.
- Stay abreast of industry trends, emerging technologies, and regulatory standards relevant to spine medical devices.
- Designs or directs design work for manufacturability, inspectability and optimum cost
- Conducts or participates in root cause analysis for problem solving
- Contributes to generation of a comprehensive protocol for testing/analyzing the product
- Coordinating product evaluation and establishing user needs directly with surgeon
- Proven track record of successfully leading engineering teams and delivering complex projects on time and within budget.
- Strong technical expertise in mechanical design, materials science, and manufacturing processes relevant to medical devices.
- In-depth knowledge of regulatory requirements and quality standards applicable to spine medical devices (e.g., FDA QSR, ISO
- Knowledge of medical device manufacturing documentation for product release
- Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively across functional teams and external customers.
- Experience with CAD software (e.g., SolidWorks) and finite element analysis (FEA) tools preferred.
- Prior experience in the spine industry and familiarity with relevant anatomical considerations and surgical techniques is a plus.
- Candidate must have demonstrated self-directed working capabilities.
- Demonstrate ability to methodically investigate and resolve problems using current technology.
- Knowledge of project management tools.
- Comfortable working in a fast paced, cross disciplinary environment
- Able to work with minimal direction towards completing project tasks
- Demonstrated good written and verbal communication skills including presentation skills.
- Leads or participates in the creation and improvement of processes
- Microsoft Office Suite and Project
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree (MS or PhD) preferred.
- Minimum of 7 years of experience in the design and development of spine medical devices or orthopedic implants. Managerial experience preferred.
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Development Engineer Manager - Westminster, United States - Highridge Medical
Description
Job Summary: *****No Third Party Recruiters*****
We are seeking an experienced Engineering Manager to lead our dynamic engineering team in the development of innovative spine medical devices. The Engineering Manager will play a pivotal role in driving the design, development, and commercialization of next-generation spinal implants and instrumentation. This position offers an exciting opportunity to collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to bring novel solutions to market.
Principal Duties and Responsibilities:
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
Education/Experience Requirements
Travel Requirements
Up to 20%
